Stroke
Conditions
Keywords
Ischemic, Acute
Brief summary
ARTESp is a prospective multicenter study in which the pREset thrombectomy system (phenox GmbH\* Germany) will be examined. The effectiveness, safety and the long-term success when using the pREset to treat acute occlusions of cerebral vessels will be analyzed. \*German: Gesellschaft mit beschränkter Haftung, limited liability company
Detailed description
ARTESp is a prospective multicenter study in which the pREset thrombectomy system (phenox GmbH Germany) will be examined. The effectiveness, safety and the long-term success when using the pREset to treat acute occlusions of cerebral vessels will be analyzed. In this study the market-approved, self-expandable stent retriever (pREset, phenox GmbH, Germany) will be used to achieve a direct flow recovery. The thrombectomy system will be unfolded directly in the vessel occlusion. In a second step, the system and the thrombus will be pulled back into the guide catheter. It is planned to enroll 100 patients at the age of 18 until 85 years, with a NIHSS (National Institutes of Health Stroke Scale) ≥ 8 and ≤ 30. The preconditions for study enrollment are the written consent of the patient or of the legal representative and the fulfillment of all mentioned inclusion and exclusion criteria. Pregnant women are excluded from study participation.The clinical interventions are in accordance with the clinical standard of care for the treatment of this patient population. The mRS (Modified Rankin Scale) on day 30, the NIHSS on day 90 and an imaging procedure on day 90 may be performed by the study site provided that it corresponds to the clinical standards of the study site.
Interventions
DEVICEpREset thrombectomy retriever
Interventional recanalization of acute cerebral vessel occlusions with the pREset thrombectomy system alone or in combination with intravenous or intraarterial thrombolytics (rt-PA).
Sponsors
Phenox GmbH
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
* Patient age ≥ 18 and ≤ 85 years. * Patients with acute-onset stroke in the 0-6 hour time window for cerebral onset of symptoms and in angiography with a TICI reperfusion (Thrombolysis in Cerebral Infarction) value of 0 or 1 of at least one major cerebral artery (carotid artery, A. media , anterior cerebral artery, basilar artery, vertebral artery, posterior cerebral artery). * NIHSS (National Institutes of Health Stroke Scale) ≥ 8 * Signed Informed Consent by patient / legal representative to participate in the study.
Exclusion criteria
* Pregnancy * Demarcated infarcted area in the initial Cranial CT or intracranial haemorrhage, * Rapid improvement of neurological symptoms * NIHSS \> 30 * Anticoagulation with warfarin with INR (international normalized ratio) \> 3.0, * Platelets \<30,000, * Glucose \<50mg/dl, * Life expectancy \<90 days
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Neurological Condition of the Patient | 90 days after treatment | modified Rankin Scale (mRS) Neurological Condition is measured by the Modified Rankin Scale (mRS). This scale ranges from 0 - 6: 0 = No symptoms at all; 1. = able to carry out all usual duties and activities; 2. = unable to carry out all previous activities, but able to look after own affairs without assistance; 3. = requiring some help, but able to walk without assistance; 4. = unable to walk without assistance and unable to attend to own bodily needs without assistance; 5. = bedridden, incontinent and requiring constant nursing care and attention; 6. = dead |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Neurological Condition of the Patient | 24 to 72 hr after treatment | The National Institutes of Health Stroke Scale (NIHSS) is a commonly used measure to assess the severity of a stroke. All items are rated and scores are added at the end. A higher score corresponds to a more severe stroke. Assessed are: 1. Level of Conciousness (LOC) (0-3) 1a. LOC Questions (0-2) 1b. LOC Commands (0-2) 2. Best Gaze (0-2) 3. Visual (0-3) 4. Facial palsy (0-3) 5. Motor arm (0-4) 6. Motor leg (0-4) 7. Limb ataxia (0-2) 8. Sensory (0-2) 9. Best Language (0-3) 10. Dysarthria (0-2) 11. Extinction and Inattention (0-2) CLASSIFICATION: 0 No stroke symptoms 1-4 Minor stroke 5-15 Moderate stroke 16-20 Moderate to severe stroke 21-42 Severe stroke As published by ninds.nih.gov: http://www.ninds.nih.gov/doctors/NIH\_Stroke\_Scale.pdf |
| Intracranial Hemorrhage (ICH) | 24 hr after treatment | Intracranial hemorrhage was assessed via imaging material (e.g. Digital Subtraction Angiography - DSA or CT) as forwarded by the clinical sites. |
| Time From Groin Puncture to Recanalization | during intervention, up to 3 hr | — |
| Recanalization of the Target Vessel | at the end of intervention, up to 3 hr | original Thrombolysis in Cerebral Infarction score (o-TICI) The TICI scale indicates perfusion of an occluded blood vessel, it is used in angiographic imaging. Grade 0 = no perfusion Grade 1 = Penetration with minimal perfusion. The contrast material passes beyond the area of obstruction but fails to opacify the entire cerebral bed distal to the obstruction for the duration of the angiographic run, Grade 2a = Only partial filling (\<2/3) of the entire vascular territory is visualized, Grade 2b = Complete filling of all of the expected vascular territory is visualized, but the filling is slower than normal, Grade 3 = complete perfusion. |
| No. of Passages Needed to Reach the Final TICI Score With pREset | during intervention, up to 3 hr | — |
Countries
Germany
Participant flow
Recruitment details
115 patients started the study, but little by little, 15 patients were excluded/discontinued due to screening failure or withdrawn consent.
Pre-assignment details
No assignment to groups was performed due to single-arm study.
Participants by arm
| Arm | Count |
|---|---|
| All Patients Treated with pREset Thrombectomy Retriever | 100 |
| Total | 100 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Screening failure | 12 |
| Overall Study | Withdrawal by Subject | 3 |
Baseline characteristics
| Characteristic | All Patients |
|---|---|
| Age, Continuous | 68.3 years STANDARD_DEVIATION 13.8 |
| Region of Enrollment Germany | 100 participants |
| Sex: Female, Male Female | 55 Participants |
| Sex: Female, Male Male | 45 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 24 / 100 |
| serious Total, serious adverse events | 7 / 100 |
Outcome results
Primary
Neurological Condition of the Patient
modified Rankin Scale (mRS) Neurological Condition is measured by the Modified Rankin Scale (mRS). This scale ranges from 0 - 6: 0 = No symptoms at all; 1. = able to carry out all usual duties and activities; 2. = unable to carry out all previous activities, but able to look after own affairs without assistance; 3. = requiring some help, but able to walk without assistance; 4. = unable to walk without assistance and unable to attend to own bodily needs without assistance; 5. = bedridden, incontinent and requiring constant nursing care and attention; 6. = dead
Time frame: 90 days after treatment
Population: All Patients
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| All Patients | Neurological Condition of the Patient | mRS 0 | 23 patients |
| All Patients | Neurological Condition of the Patient | mRS 0-1 | 52 patients |
| All Patients | Neurological Condition of the Patient | mRS 0-2 | 60 patients |
| All Patients | Neurological Condition of the Patient | mRS 3-5 | 29 patients |
| All Patients | Neurological Condition of the Patient | mRS 6 | 7 patients |
| All Patients | Neurological Condition of the Patient | Lost to follow-up | 4 patients |
Secondary
Intracranial Hemorrhage (ICH)
Intracranial hemorrhage was assessed via imaging material (e.g. Digital Subtraction Angiography - DSA or CT) as forwarded by the clinical sites.
Time frame: 24 hr after treatment
Population: All Patients
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| All Patients | Intracranial Hemorrhage (ICH) | 14 patients |
Secondary
Neurological Condition of the Patient
The National Institutes of Health Stroke Scale (NIHSS) is a commonly used measure to assess the severity of a stroke. All items are rated and scores are added at the end. A higher score corresponds to a more severe stroke. Assessed are: 1. Level of Conciousness (LOC) (0-3) 1a. LOC Questions (0-2) 1b. LOC Commands (0-2) 2. Best Gaze (0-2) 3. Visual (0-3) 4. Facial palsy (0-3) 5. Motor arm (0-4) 6. Motor leg (0-4) 7. Limb ataxia (0-2) 8. Sensory (0-2) 9. Best Language (0-3) 10. Dysarthria (0-2) 11. Extinction and Inattention (0-2) CLASSIFICATION: 0 No stroke symptoms 1-4 Minor stroke 5-15 Moderate stroke 16-20 Moderate to severe stroke 21-42 Severe stroke As published by ninds.nih.gov: http://www.ninds.nih.gov/doctors/NIH\_Stroke\_Scale.pdf
Time frame: 24 to 72 hr after treatment
Population: All Patients
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| All Patients | Neurological Condition of the Patient | 5 NIHSS score |
Secondary
No. of Passages Needed to Reach the Final TICI Score With pREset
Time frame: during intervention, up to 3 hr
Population: 100 patients harboured 109 vessel occlusions
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| All Patients | No. of Passages Needed to Reach the Final TICI Score With pREset | 1.7 passes | Standard Deviation 0.96 |
Secondary
Recanalization of the Target Vessel
original Thrombolysis in Cerebral Infarction score (o-TICI) The TICI scale indicates perfusion of an occluded blood vessel, it is used in angiographic imaging. Grade 0 = no perfusion Grade 1 = Penetration with minimal perfusion. The contrast material passes beyond the area of obstruction but fails to opacify the entire cerebral bed distal to the obstruction for the duration of the angiographic run, Grade 2a = Only partial filling (\<2/3) of the entire vascular territory is visualized, Grade 2b = Complete filling of all of the expected vascular territory is visualized, but the filling is slower than normal, Grade 3 = complete perfusion.
Time frame: at the end of intervention, up to 3 hr
Population: 100 patients harboured 109 vessel occlusions
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| All Patients | Recanalization of the Target Vessel | TICI 2b | 40 number of vessels |
| All Patients | Recanalization of the Target Vessel | TICI 0 | 7 number of vessels |
| All Patients | Recanalization of the Target Vessel | TICI 1 | 2 number of vessels |
| All Patients | Recanalization of the Target Vessel | TICI 2a | 8 number of vessels |
| All Patients | Recanalization of the Target Vessel | TICI 3 | 52 number of vessels |
Secondary
Time From Groin Puncture to Recanalization
Time frame: during intervention, up to 3 hr
Population: All Patients
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| All Patients | Time From Groin Puncture to Recanalization | 40 minutes |